DECENTRALIZED CLINICAL TRIAL ON SLEEP

Clinical study to explore tolerability and benefit of a dietary supplement for subjects with sleep complaints.

• Very fast subject recruitment and very high compliance and retention rate due to the use of an easy-to-use electronic diary and only one in-person doctor visit.
• The remote study approach was very well accepted across all age groups.
• Less on-site visits and fast recruitment reduced costs of about 50% compared to a traditional study approach.

Methodology

• At study start, there was a screening visit at the study site to check eligibility. Then, subjects consumed the dietary supplement for 3 weeks and recorded any study-relevant data in an electronic questionnaire via their own smartphone, tablet, or computer daily.

• The electronic questionnaire was sent to the participants on a daily basis via email or text message. It contained questions regarding:
  • time in bed
  • time to fall asleep
  • number of awakenings in the night
  • total duration of wake time during the night
  • overall quality of sleep
  • sense of well-being during the day
  • tolerability
  • adverse events
• The study team had a “live view” on subject progress by use of a connected dashboard and could quickly identify and re-engage subjects in case of missed data entries or in case any clarification was needed